United States v. Rochester Regional Health

CourtDistrict Court, W.D. New York
DecidedJune 11, 2025
Docket1:23-cv-00438
StatusUnknown

This text of United States v. Rochester Regional Health (United States v. Rochester Regional Health) is published on Counsel Stack Legal Research, covering District Court, W.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Rochester Regional Health, (W.D.N.Y. 2025).

Opinion

UNITED STATES DISTRICT COURT STATES DISTRIGS WESTERN DISTRICT OF NEW YORK Comin JUN 11 2025 DNBORAT COME AD. AMERICA ex rel.

Plaintiff/Relator, v. 23-CV-438 (JLS)

ROCHESTER REGIONAL HEALTH and UNITED MEMORIAL MEDICAL CENTER, Defendants.

DECISION AND ORDER Relator Deborah Conrad brought this False Claims Act (“FCA”) case against Rochester Regional Health and United Memorial Medical Center (collectively, “RRH”). Dkt. 1, 34. RRH moved to dismiss Relator’s amended complaint. See Dkt. 37-38. For the reasons set forth below, the motion to dismiss is granted in part and denied in part. PROCEDURAL HISTORY Relator Conrad filed the original complaint under seal on May 17, 2023. Dkt. 1. The United States declined to intervene, Dkt. 7, and the Court unsealed the case. Dkt. 8. RRH filed a motion to dismiss on May 28, 2024. Dkt. 21. Relator responded (Dkt. 27), and RRH replied. Dkt. 28. The parties appeared for oral argument on

August 20, 2024, and this Court granted the motion to dismiss with leave to amend. See Dkt. 29-30. Relator then filed an amended complaint that RRH again moved to dismiss. Dkt. 34, 37-38. Relator responded (Dkt. 45), and RRH replied. Dkt. 46. The Court held oral argument on March 11, 2025. See Dkt. 47. AMENDED COMPLAINT Relator alleges that RRH violated the FCA because it knowingly failed to report adverse events to the Vaccine Adverse Event Reporting System (“VAERS”)!, but nevertheless submitted claims for payment to the United States, through the Centers for Disease Control and Prevention’s (“CDC”) COVID-19 Vaccination Program. See Dkt. 34 3. Relator is a Physician Assistant. Id. § 11. She was employed by RRH until she was fired on October 6, 2021. Id. J] 49, 90. During her employment, Relator allegedly observed RRH disregard its reporting obligations. Id. § 5. Relator alleges that RRH submitted “thousands” of claims for payment, despite failing to comply with its reporting obligations. Id. { 6. She also alleges that she saw RRH patients suffer serious adverse events following the COVID shot. Jd. § 53. And she learned that these events must be reported through VAERS. Id. { 54. Because Relator had concerns about RRH’s reporting efforts, she took the initiative to submit VAERS reports on her own,

1 VAERS is a “national early warning system to detect possible safety problems in vaccines used in the United States.” VACCINE ADVERSE EVENT REPORTING SYSTEM, https://vaers.hhs.gov/reportevent.html (last visited June 9, 2025).

sometimes even after her shift ended. See id. § 55. She allegedly submitted 160 VAERS reports. Jd. But she claims the problem “escalated” from May 27, 2021 to October 6, 2021, when RRH prevented her from submitting 170 serious adverse events to VAERS. Id. { 5. Noteworthy here, Relator alleges specific examples, including: e Patient E.F., who presented with sudden shortness of breath and fatigue, one day after receiving the vaccine; e Patient S.B., who experienced syncope, convulsions, fevers, chills, and myalgias, one day after receiving the vaccine; e Patient J.F., who presented with arm pain and induration, three days after receiving the vaccine; e Patient M.D., who was admitted due to hypertensive urgency; e Patient N.M., who was admitted for bradycardia, AMS, and weakness; e Patient D.A., who experienced an unknown illness; and e Patient C.M., who experienced dizziness and unsteady gate. Id. § 91. RRH had administered COVID shots to Patients M.D., N.M., D.A., and C.M., but the provider for the remaining patients in paragraph 91 is “unknown.” Id. Relator claims that she tried numerous times to escalade the issue to her higher leadership, but she was turned away. See, e.g., id. J] 57, 68, 65, 68, 69, 70, 71, 72, 73, 74, 75, 77, 78, 81, 86, 87. She further alleges that RRH knew it needed to report to VAERS, but failed to provide proper education and training to staff. See

id. {{{ 58, 68, 76. RRH fired Relator after her several attempts to address the issue with RRH. See id. 90. Relator alleges that RRH, as a vaccination provider, must report to VAERS under statute and contract. Id. {| 44. She asserts that VAERS reporting is mandatory under statute—specifically, the National Childhood Vaccine Injury Act (“NCVIA”) and the emergency use authorization provisions under the Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3 (““EUA”). See id. J§ 6, 19-38. She also alleges that RRH’s reporting obligation is an “express material condition” of payment under the Vaccination Program Provider Agreement (“Provider Agreement”) that RRH agreed to. Id. J] 6, 39-48. The amended complaint contains claims for: (1) presenting and causing false claims, in violation of 31 U.S.C. § 3729(a)(1)(A), see id. |] 123-27; (2) false records, in violation of 31 U.S.C. § 3729(a)(1)(B), see id. ¢] 128-33; (3) conspiracy, in violation of 31 U.S.C. § 3729(a)(1)(C), see id. 134-39; (4) reverse false claims, in violation of 31 U.S.C. § 3729(a)(1)(G), see id. 9 140—48; (5) retaliation, in violation of 31 U.S.C. § 3730(h), see id. | 149-56; and (6) violation of New York Labor Laws §§ 740 and 741, see id. 157-61. LEGAL STANDARDS I. Motion to Dismiss On a motion pursuant to Federal Rule of Civil Procedure 12(b)(6), a “court’s task is to assess the legal feasibility of the complaint.” Lynch v. City of New York, 952 F.3d 67, 75 (2d Cir. 2020). The court “must take the facts alleged in the

complaint as true, drawing all reasonable inferences in [the plaintiffs] favor.” In re NYSE Specialists Sec. Litig., 503 F.3d 89, 91 (2d Cir. 2007). To survive a Rule 12(b)(6) motion, a complaint must contain sufficient factual matter, accepted as true, to “state a claim to relief that is plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) Gnternal quotation marks and citation omitted). Courts “are not bound to accept as true a legal conclusion couched as a factual allegation,” and “(t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Jd. Gnternal quotation marks and citation omitted). This standard demands “more than a sheer possibility that a defendant has acted unlawfully.” Jd. Plausibility depends on many considerations: “the full factual picture presented by the complaint, the particular cause of action and its elements, and the existence of alternative explanations so obvious that they render [the] plaintiffs inferences unreasonable.” Fink v. Time Warner Cable, 714 F.3d 739, 741 (2d Cir. 2018) (internal quotation marks and citation omitted). II. False Claims Act and Rule 9(b) The False Claims Act is an anti-fraud statute “enforced not just through litigation brought by the Government itself, but also through civil qui tam actions that are filed by private parties, called relators, in the name of the Government.” United States ex rel. Chorches for Bankr. Est. of Fabula v. Am. Med.

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United States v. Rochester Regional Health, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-rochester-regional-health-nywd-2025.